Elevated Placental Growth Factor at 11 to 13 weeks 6 days period of gestation as a predictor of Gestational diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- To determine if elevated PlGF can predict GDM later on in pregnancy
研究概览
简要总结
This study , titles “Elevated placental growth factor at 11-13 weeks
6 days period of gestation as a predictor of gestational diabetes
mellitus,” is a prospective observational cohort study conducted at a
tertiary care hospital, utilizing data collected over the Antenatal
period , starting from time of NT Scan till termination of pregnancy ,
of patients that fulfil the inclusion criteria . Data collected over the
antenatal period will include PlGF levels at the time of NT Scan and
aneuplaoidy screening ( part of regular ANC , done after 11
completed weeks but before 14 completed weeks , that is by 13
weeks 6 days of gestation) , OGTT/GCT levels ( part of ANC , done
between 24-28 weeks in regular clinical practice) , maternal details
such as GPLA score, anthropometric measurements ( 1 st trimester
BMI, height) collected in 1 st trimester at the time of NT scan /
Aneuploidy screening . Patients will be followed up after NT
scan/aneuploidy screening during regular ANC visits . OGTT values (
done as part of regular ANC visit between the POG 24-28 weeks) will
be recorded in a proforma and patient will be classified as GDM
(gestational diabetes mellitus) and non GDM based on the same
according to standard cut-offs used in regular practice. Subsequent
FBS/PPBS values ( part of routine ANC tests for GDM patients) will
be recorded in the same proforma. Data will be entered in machine
learning tool (Random forest ) to help in formulation of a model that
will help predict GDM development . Ethical approval will be
obtained , with all data anonymized to maintain confidentiality. The
study’s findings can help in providing a valuable early predictor of
GDM in pregnancy that could potentially decrease both maternal and
fetal morbidity and mortality risks.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 48.00 Year(s)(—)
- 性别
- Female
入选标准
- •Singleton pregnancies at 11-13 weeks 6 days of gestation at the time of combined screening by USG and biochemistry markers in the maternal serum and who continue antenatal check ups in our hospital.
- •Willing to participated in the study and give informed consent.
排除标准
- •Multiple pregnancies
- •Pregnancies with pre-existing hypertensive disorders or Pre- existing Diabetes Mellitus ( type 1 and 2 ), previous pregnancies with GDM
- •Pregnancies with known chromosomal abnormalities and/or structural defects
- •Pregnancies that resulted in IUD or abortions
- •Pregnancies with early onset FGR.
结局指标
主要结局
To determine if elevated PlGF can predict GDM later on in pregnancy
时间窗: At the end of pregnancy
次要结局
未报告次要终点
研究者
Gauri Mann
Kasturba Hospital , Manipal
